Company

PfizerSee more

addressAddressEngland
type Form of workFull Time, Flexible working available, Permanent
salary SalaryNegotiable
CategoryHuman Resources

Job description

ROLE SUMMARY
We have an exciting opportunity for a Senior Manager to join our Global Regulatory Affairs Vaccines Team as regional EU Lead, Regional Regulatory Strategist (RRS). This is an excellent opportunity to join a dynamic team with a leading vaccines company. We are looking for candidates with a dynamic and agile profile and a scientific background, and strong clinical/safety regulatory experience.
Note this is not a regulatory CMC, labelling, or submissions role. The candidate should be passionate for vaccines, be willing to learn and advance in their career.As well as supporting the regulatory strategy from a regional perspective, you will partner with project teams and other customer groups to ensure regulatory requirements meet business needs.
We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer vaccines.
ROLE RESPONSIBILITIES

  • Reports to the Global Regulatory Portfolio Lead
  • Assist in developing and implementing key clinical/safety regulatory strategy that aligns with business needs, including growth projects and activities relating to maintaining registrations, product defence and regulatory compliance.
  • Contribute to regulatory strategy and operational activities for projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
  • Participate in Regulatory and cross functional teams working closely with Clinical, Safety, Medical, CMC, submissions, labelling and commercial colleagues for assigned projects/products.
  • With appropriate supervision, direct and/or indirect liaison with Health Authorities (in conjunction with Country Regulatory Leads (CRLs)) to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.


WHAT YOU WILL ACHIEVE
You will represent Pfizer as an Approval Liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the Regulatory Liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.
As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.
It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe.
HOW YOU WILL ACHIEVE IT

  • Develop ideas and lead projects across the division and develop plans to achieve objectives.
  • Develop regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management.
  • Provide strategic contribution to the country or cluster markets that give support leadership team.
  • Understand local regulations and developing trends in the local regulatory environment of the countries that support and provide assessment of the impact to key stakeholders.
  • Maintain licenses in compliance with local regulations of the countries by ensuring that corporate regulatory processes, Standard Operating Procedures (SOP) and systems are in place, also ensure team is properly trained in these systems and procedures. 
  • Maintain and update the Local Product Document (labelling) in accordance with relevant regulations and SOPs.
  • Implement systems, processes and procedures relating to regulatory strategy productivity improvements, ensure that these facilitate share information across the relevant lines.
  • Deliver project /product strategy including label and risk assessment for assigned projects/product.
  • Ensures business compliance and implementation of and adherence to Regulatory standards.
  • Develop and enhance relationships with key external agencies, strong partnerships with in-country or cluster markets that give support to facilitate the development and implementation of registration strategies.


QUALIFICATIONS
Must-Have

  • Bachelor's Degree (BA/BS) and extensive relevant experience.
  • Knowledge of the Regional and Global regulatory environment.
  • Knowledge of drug development practice, rules, regulations and guidelines.
  • Understanding of business and financial environment.

Nice-to-Have

  • Master's degree (MA/MBA/MS) and relevant extensive experience.
  • Doctorate (PhD/PharmD/JD) with demonstrable experience.
  • Thinks strategically with good project management skills.
  • Ability to manage multiple projects, create and manage project timelines.


Work Location Assignment: Flexible

Refer code: 3126498. Pfizer - The previous day - 2024-04-02 22:10

Pfizer

England
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